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cbd oil trials

There are many claims about the beneficial use of medicinal cannabis products for a wide range of conditions. Most of these claims lack solid scientific backing, because cannabis is an illegal drug and it has been difficult for researchers to run research trials.

Clinical trials are research investigations in which people volunteer to test new medications and treatments as a means to manage various medical conditions.

There are two schemes under which clinical trials involving therapeutic goods, including medicinal cannabis may be conducted in Australia:

Research on medicinal cannabis

The results of ongoing clinical trials will establish an evidence base for medicinal cannabis and inform future treatment decisions.

The 2 main active components that are the current focus of research are tetrahydrocannabinol (THC) and cannabidiol (CBD). However, there are many other components that may be beneficial and will be the focus of research in the future.

There are different types of cannabis, and these can contain over 400 various compounds in the raw form. We need to research cannabis products using known stable active components, so that treatment outcomes can be compared and replicated.

The current research aims to establish which cannabis compounds and dosage levels are effective, and for which conditions and symptoms.

CBD stands for cannabidiol. It is the second most prevalent of the active ingredients of cannabis (marijuana). While CBD is an essential component of medical marijuana, it is derived directly from the hemp plant, which is a cousin of the marijuana plant. While CBD is a component of marijuana (one of hundreds), by itself it does not cause a "high." According to a report from the World Health Organization, "In humans, CBD exhibits no effects indicative of any abuse or dependence potential…. To date, there is no evidence of public health related problems associated with the use of pure CBD."

CBD is commonly used to address anxiety, and for patients who suffer through the misery of insomnia, studies suggest that CBD may help with both falling asleep and staying asleep.

How is cannabidiol different from marijuana?

CBD has been touted for a wide variety of health issues, but the strongest scientific evidence is for its effectiveness in treating some of the cruelest childhood epilepsy syndromes, such as Dravet syndrome and Lennox-Gastaut syndrome (LGS), which typically don’t respond to antiseizure medications. In numerous studies, CBD was able to reduce the number of seizures, and, in some cases, it was able to stop them altogether. Videos of the effects of CBD on these children and their seizures are readily available on the Internet for viewing, and they are quite striking. Recently the FDA approved the first ever cannabis-derived medicine for these conditions, Epidiolex, which contains CBD.

Some CBD manufacturers have come under government scrutiny for wild, indefensible claims, such that CBD is a cure-all for cancer, which it is not. We need more research but CBD may be prove to be an option for managing anxiety, insomnia, and chronic pain. Without sufficient high-quality evidence in human studies we can’t pinpoint effective doses, and because CBD is currently is mostly available as an unregulated supplement, it’s difficult to know exactly what you are getting. If you decide to try CBD, talk with your doctor — if for no other reason than to make sure it won’t affect other medications you are taking.

Side effects of CBD include nausea, fatigue and irritability. CBD can increase the level in your blood of the blood thinner coumadin, and it can raise levels of certain other medications in your blood by the exact same mechanism that grapefruit juice does. A significant safety concern with CBD is that it is primarily marketed and sold as a supplement, not a medication. Currently, the FDA does not regulate the safety and purity of dietary supplements. So, you cannot know for sure that the product you buy has active ingredients at the dose listed on the label. In addition, the product may contain other (unknown) elements. We also don’t know the most effective therapeutic dose of CBD for any particular medical condition.

This research was funded solely through the Institute of Cannabis Research at Colorado State University – Pueblo.

Pre-clinical research has reported that there may be promise in patients with treatment-resistant seizure disorders, the CDKL5 deficiency disorder, or Aicardi, Dup15q, and Doose syndromes; however, due to the variability in dosage between these studies, we aim to focus only on completed clinical trial data (Devinsky et al., 2018; Szaflarski et al., 2018). Another company, INSYS Therapeutics Inc. (Phoenix, AZ), has also funded Phase 1 and 2 clinical trials to investigate a non-plant-based cannabidiol oral solution at various dosages to treat resistant seizure disorders in pediatric patients (ages 1–17). Dosages of 10, 20, and 40 mg/kg/day were provided to 20, 20, and 21 patients, respectively. This study mainly aimed to provide the pharmacokinetics of CBD, as well as the safety and dosing information; however, they did report decreases from the baseline number of seizures. Specifically, there was a reduction of tonic seizures per day and a reduction of atonic seizures per day for the respective dosing groups. While there were no serious adverse effects and non-serious adverse events were observed including anemia (10%, 25%, and 19.05%), somnolence (15%, 15%, and 33.3%), and flatulence (14.29%) in the 40 mg/kg/day dosing group (INSYS Therapeutics Inc, 2016; Parikh, 2018).

Clinical trials results from epidiolex-focused studies.

Conflict of Interest

Overall, through presenting data from 16 completed clinical trials involving CBD-based drugs, we intend to inform clinicians about the current status of CBD-based drugs and guide future clinical trial designs for cannabinoid medications to have objective measurements of success, as well as detrimental side effects.

To summarize the study sample sizes, dosing regiments, and effectiveness of using CBD-based drugs as a treatment option, we have created a table to describe the results and provided their sources to be able to further investigate the topics that have been discussed ( Table 1 ).

While the study designs are inconsistent, the drug and dosage being examined also varies significantly between studies. While Epidiolex has a concentration of 100 mg/ml and a maximum recommended dose of 20 mg/kg/day, some studies examined drastically deviated from that recommendation (GW Biosciences, 2018). The study performed to examine CBD’s efficacy on UC patients used 1–5 50 mg capsules; whereas, the dosage ranged from 400 mg to 800 mg doses in studies for drug-cessation (Hurd, 2013; Hill, 2016; Irving et al., 2018). This could explain the differences in the side effects of each study; however, further work is needed to conclude if the variance was due to CBD concentration or delivery method. Other studies, such as the Yale’s study into cognitive decline used a fixed-dose of 600 mg of “active cannabidiol”, but did not specify delivery mechanism in their clinical trial results, which makes it difficult to compare the results to other clinical trials (Boggs et al., 2018). Along this note, it should be required to describe in detail how the dose was given since some studies had specified they increasingly titrated the dose of CBD, which allows the patient to build a tolerance to the drug before receiving the maximum dose (GW Biosciences, 2018).

Ulcerative colitis (UC), among other gastrointestinal (GI) diseases, are becoming increasingly prevalent in western countries and their etiology is still unknown (Hasenoehrl et al., 2017). With anecdotal evidence of beneficial cannabinoids for patients with GI ailments, UC was another indication that GW Pharmaceuticals investigated, and they completed Phase 2 clinical trials in 2018 (Irving et al., 2018). This multi-center study was performed in a randomized, double-blind, placebo-controlled, and parallel-group study design. Over 10 weeks, various dosages (50–250 mg) of Epidiolex were administered twice a day to 29 patients suffering from UC, and a placebo was given to 31 patients. The participants first entered into a 2-week trial to identify the maximum dose tolerance (up to 250 mg twice a day for each patient in the Epidiolex group, which they remained at that dose for the remainder of the trial. Their primary goal was to observe changes in the Mayo score (an indicator of UC severity; < 2 = remission of UC), and their secondary outcomes included measuring irritable bowel syndrome responses, UC symptom measurements, and calprotectin levels. Decreases in the Mayo score (−2.0 in treatment compared to −1.2 in control) and in the levels of calprotectin in the patients’ fecal matter (−91.6, SD=295.77. in treatment; −51.3, SD=289.32 in placebo) were observed in the treatment group. There were no serious adverse effects reported by the treatment group and no mortality reported; however, 96.55% of the treatment group (76.44% of placebo group) reported some other adverse events, including dizziness (46%), somnolence (34%), and nausea (27%) (Irving et al., 2018).